EN ISO 9919:2009

Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)

For the purposes of ISO 9919:2005, the Scope given in IEC 60601-1:1988 (Clause 1) applies, except as follows.
Amendment (add at the end of 1.1):
ISO 9919:2005 specifies particular requirements for the basic safety and essential performance of pulse oximeter equipment intended for use on humans. This includes any part necessary for normal use, e.g. the pulse oximeter monitor, pulse oximeter probe, probe cable extender.
These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, that has been reprocessed.
The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate on patients in healthcare institutions as well as on patients in home care.
ISO 9919:2005 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that requires a blood sample from the patient.
ISO 9919:2005 is not applicable to pulse oximeter equipment solely intended for fetal use.
ISO 9919:2005 is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the patient environment.
The requirements of ISO 9919:2005 which replace or modify requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.

Medizinische elektrische Geräte Besondere Festlegungen für die grundlegende Sicherheit und die wesentlichen Leistungsmerkmale von Pulsoximetriegeräten für den medizinischen Gebrauch (ISO 9919:2005)

IEC 60601-1:1988, Abschnitt 1 gilt mit folgenden Abweichungen.
Ergänzung (nach 1.1):
Diese Allgemeinen Festlegungen spezifizieren besondere Anforderungen für die grundlegende Sicherheit
und die wesentlichen Leistungsmerkmale von Pulsoximetriegeräten. Dies beinhaltet alle Teile, die für den
bestimmungsgemäßen Gebrauch erforderlich sind, z. B. den Pulsoximetriemonitor, den Pulsoximetriesensor
oder das Sensorverlängerungskabel.
Diese Anforderungen gelten auch für Pulsoximetriegeräte einschließlich Pulsoximetriemonitoren, Pulsoximetriesensoren
und Sensorverlängerungskabel, die wiederaufgearbeitet wurden.
Der bestimmungsgemäße Gebrauch von Pulsoximetriegeräten beinhaltet, ist aber nicht begrenzt auf die
Abschätzung der arteriellen Sauerstoffhämoglobinsättigung und Pulsfrequenz bei Patienten innerhalb und
außerhalb des Krankenhauses, einschließlich der Anwendung in häuslicher Umgebung.
* Diese Besonderen Festlegungen gelten nicht für Pulsoximetriegeräte, die für den Gebrauch in Laborforschungsanwendungen
bestimmt sind, und Pulsoximeter, die eine Blutprobe von Patienten benötigen.
Diese Besonderen Festlegungen gelten nicht für Pulsoximetriegeräte, die für den Einsatz bei Ungeborenen
bestimmt sind;
Diese Besonderen Festlegungen gelten nicht für entfernt aufgestellte oder gekoppelte Geräte, die SpO2-
Werte anzeigen und die sich außerhalb der Patientenumgebung befinden.
Anforderungen dieser Besonderen Festlegungen, die Anforderungen der IEC 60601-1:1988 einschließlich
ihrer Änderungen 1 (1991) und 2 (1995) ersetzen oder ändern, haben Vorrang vor den entsprechenden
Allgemeinen Festlegungen.

Appareils électromédicaux - Règles particulières de sécurité et performances essentielles du matériel utilisé pour les oxymètres de pouls à usage médical (ISO 9919:2005)

Pour les besoins de l'ISO 9919:2005, le domaine d'application de la CEI 60601-1:1998 (Article 1) s'applique avec les modifications et les ajouts suivants.
Amendement (à ajouter à la fin de 1.1):
L'ISO 9919:2005 spécifie les exigences particulières de sécurité minimale et de performances essentielles des oxymètres de pouls conçus pour une utilisation chez les êtres humains. Sont inclus tous les éléments de l'appareil nécessaires pour une utilisation normale, tels que le moniteur de l'oxymètre de pouls, le capteur de l'oxymètre de pouls, le câble de raccordement du capteur.
Ces exigences s'appliquent de la même manière aux oxymètres de pouls, y compris aux moniteurs d'oxymètre de pouls, aux capteurs d'oxymètre de pouls et aux câbles de raccordement du capteur, qui ont été remis en état.
L'usage prévu des oxymètres de pouls inclut notamment, sans toutefois s'y limiter, l'estimation de la saturation en oxygène de l'hémoglobine artérielle et de la fréquence du pouls chez des patients, en établissement de soins ainsi que chez les patients soignés à domicile.
L'ISO 9919:2005 ne s'applique pas aux oxymètres de pouls destinés à être utilisés dans le cadre de recherches en laboratoire, de même qu'aux oxymètres nécessitant un échantillon de sang du patient.
L'ISO 9919:2005 ne s'applique pas aux oxymètres de pouls destinés à surveiller un fœtus.
L'ISO 9919:2005 ne s'applique pas aux dispositifs distants ou esclaves (secondaires) qui affichent les valeurs de la SpO2 et qui sont situés à l'extérieur de l'environnement du patient.
Les exigences de l'ISO 9919:2005 qui remplacent ou modifient les exigences de la CEI 60601-1:1998 et ses Amendements 1 (1991) et 2 (1995), sont destinées à avoir la priorité sur les exigences générales correspondantes

Elektromedicinska oprema - Posebne zahteve za osnovno varnost in bistvene lastnosti pulznega oksimetra za uporabo v medicini (ISO 9919:2005)

General Information

• Status: Withdrawn
• Publication Date: 07-Apr-2009
• Withdrawal Date: 31-Mar-2011
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 01-Apr-2011
• Completion Date: 01-Apr-2011
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 9919:2009 - Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)

Relations

• Replaces: EN ISO 9919:2005 - Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 80601-2-61:2011 - Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011)
• Effective Date: 09-Apr-2011

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 9919:2009
01-maj-2009
1DGRPHãþD
SIST EN ISO 9919:2005
Elektromedicinska oprema - Posebne zahteve za osnovno varnost in bistvene
lastnosti pulznega oksimetra za uporabo v medicini (ISO 9919:2005)
Medical electrical equipment - Particular requirements for the basic safety and essential
performance of pulse oximeter equipment for medical use (ISO 9919:2005)
Medizinische elektrische Geräte Besondere Festlegungen für die grundlegende
Sicherheit und die wesentlichen Leistungsmerkmale von Pulsoximetriegeräten für den
medizinischen Gebrauch (ISO 9919:2005)
Appareils électromédicaux - Règles particulières de sécurité et performances
essentielles du matériel utilisé pour les oxymètres de pouls à usage médical (ISO
9919:2005)
Ta slovenski standard je istoveten z: EN ISO 9919:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 9919:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 9919:2009

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SIST EN ISO 9919:2009
EUROPEAN STANDARD
EN ISO 9919
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 9919:2005
English Version
Medical electrical equipment - Particular requirements for the
basic safety and essential performance of pulse oximeter
equipment for medical use (ISO 9919:2005)
Appareils électromédicaux - Règles particulières de Medizinische elektrische Geräte Besondere Festlegungen
sécurité et performances essentielles du matériel utilisé für die grundlegende Sicherheit und die wesentlichen
pour les oxymètres de pouls à usage médical (ISO Leistungsmerkmale von Pulsoximetriegeräten für den
9919:2005) medizinischen Gebrauch (ISO 9919:2005)
This European Standard was approved by CEN on 14 March 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9919:2009: E
worldwide for CEN national Members.

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SIST EN ISO 9919:2009
EN ISO 9919:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative)  Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC .4

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SIST EN ISO 9919:2009
EN ISO 9919:2009 (E)
Foreword
The text of ISO 9919:2005 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 9919:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the
secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by October 2009, and conflicting national standards shall be withdrawn at
the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 9919:2005.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive.
For relationship with EC Directive, see informative Annex ZA, which is an int
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